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Biotechnology
The US Food and Drug Administration (FDA) has been asked to approve Tremfya (guselkumab) in a second indication. 16 September 2019
Pharmaceutical
European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure. 6 September 2019
Pharmaceutical
Deal-making featured prominently in the news last week, first with Amgen reaching agreement to acquire the psoriasis drug Otezla from Celgene for around $13 billion. Also, GlaxoSmithKline was seen to have done a good deal with Ionis Pharma in taking up its option on a hepatitis B program, and takeover target Celgene is still on the buying path, the latest being with Germany’s Immatics Biotechnologies on cell therapies targeting cancer. On the research front, The Medicines Company’s Phase III positivetrial results with inclisiran for LDL-cholesterol is seen likely to impact other PCSK9 inhibitors. Additionally, in the ongoing PCSK9 patent battle, Sanofi and Regeneron scored a victory over Amgen. 1 September 2019
Biotechnology
Complying with US Federal Trade Commission requirements, US biotech major Amgen has reached agreement with Celgene to acquire worldwide rights to the latter’s Otezla (apremilast), the only oral, non-biologic treatment for psoriasis and psoriatic arthritis. 26 August 2019
Biotechnology
Privately-held biotech Enteris BioPharma has granted to Cara Therapeutics a non-exclusive, royalty-bearing license to Peptelligence technology to develop, manufacture and commercialize oral Korsuva (CR845/difelikefalin) worldwide, excluding Japan and South Korea. 21 August 2019
Biotechnology
There was nice news for US biopharma major AbbVie today, as the UK health technology appraiser issued a positive guidance for its Skyrizi (risankizumab). 21 August 2019
Biotechnology
Eli Lilly has released data showing that its Taltz (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase IV IXORA-R study, which evaluated the efficacy and safety of Taltz versus rival drug Tremfya (guselkumab) in people living with moderate to severe plaque psoriasis (PsO). 15 August 2019
Biotechnology
Danish dermatology specialist LEO Pharma says it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum in the European Union and Siliq in other regions) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licensing agreement with Bausch Health. 14 August 2019
Biotechnology
Positive results for Eli Lilly’s IL-17 blocker Taltz (ixekizumab) in the Phase IV IXORA-R study will help support its use for people living with moderate to severe plaque psoriasis. 13 August 2019
Biotechnology
One of big pharma’s favorite partner companies – Regeneron Pharmaceuticals – has beaten analyst expectations with its second quarter financial results. 6 August 2019
Biotechnology
Pharma major Sanofi announced European Union (EU) approval for an extension of the marketing authorization for Dupixent (dupilumab) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 6 August 2019
Pharmaceutical
Eli Lilly today posted second-quarter 2019 financial, showing that revenue increased less than 1% to $5.64 billion from $5.59 billion driven by 6% volume growth, and beating Wall Street estimates of $5.6 billion. 30 July 2019
Biotechnology
Russian drugmaker Biocad is expanding into the therapeutic area of psoriatic drugs, through the launch of production of its new treatment Efleira (netakimab), according to recent statements by the company, reports The Pharma Letter’s local correspondent. 29 July 2019
Pharmaceutical
Just a year or two ago, shareholders at Spanish dermatology specialist Almirall would have embraced half-year financial results like those presented on Monday, but perhaps expectations have risen alongside sales and earnings. 29 July 2019
Biotechnology
Last year, Denmark-headquartered dermatology specialist LEO Pharma increased the size of its investment in R&D to 18%, compared to the 15% of the previous year. 25 July 2019
Biotechnology
British medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD), confirming that Skyrizi (risankizumab) is recommended for the treatment of severe psoriasis in adult patients who have failed conventional systemic therapies. 15 July 2019
Pharmaceutical
US pharma giant Pfizer saw its shares rise more than 1% to $43.77 by close of trading on Monday, after it announced top-line results from a Phase IV study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged three months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. 2 July 2019
Biotechnology
National Health Service patients in the UK will be the first to gain access in Europe to new skin cancer treatment, Libtayo (cemiplimab), through the Cancer Drugs Fund (CDF), it was revealed today, just a day after the drug won conditional regulatory approval from the European Commission. 2 July 2019
Biotechnology
Sun Pharmaceutical Industries has entered into a licensing agreement with a subsidiary of China Medical System Holdings (CMS) for the development and commercialization of tildrakizumab in Greater China. 1 July 2019
Pharmaceutical
On the M&A front last week, the spotlight was on AbbVie’s proposed $63 billion acquisition of troubled drugmaker Allergan, which gained a great deal of attention, as well as Bristol-Myers divestment of psoriasis drug Otezla in order to proceed with its $74 billion bid for Celegene. Research news included Conatus Pharmaceuticals’ setback with the failure of its non-alcoholic steatohepatitis (NASH) candidate CTS-2099, adding to a litany of disappointments in the search of a treatment for this liver disease. Meantime, Gilead Sciences entered into a couple of licensing deals linking up with Carna Biosciences on next-generation immuno-oncology compounds and with Nurix on cancer and other diseases. 30 June 2019
Biotechnology
New research has been published in the Journal of Allergy and Clinical Immunology (JACI) that shows treatment with amlitelimab, an anti-OX40 ligand antibody, significantly reduced symptoms of atopic dermatitis (AD) and was maintained even after treatment stopped. 9 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
Denmark’s privately-held dermatology specialist LEO Pharma and Japan’s Kyowa Kirin have revealed that they will terminate the distribution and co-promotion agreement for the psoriasis vulgaris treatment Dovobet Ointment, Gel, and Foam (calcipotriol hydrate / betamethasone dipropionate) in Japan on December 31, 2024. 1 November 2024
Biotechnology
Regeneron Pharmaceuticals today announced financial results for the third quarter of 2024 that beat expectations, but still saw its share price fall more than 6% to $866 in early trading. 31 October 2024
Biotechnology
Treatment with Tremfya (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment, says US healthcare giant Johnson & Johnson. 25 October 2024
Biotechnology
New results show Eli Lilly Ebglyss (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Dupixent (dupilumab). 25 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s Bimzelx (bimekizumab-bkzx), to treat psoriasis. 14 October 2024
Biosimilars
Bio-Thera Solutions and Hungary’s Gedeon Richter have reached an exclusive commercialization and license agreement. 14 October 2024
Biotechnology
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Pharmaceutical
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
Biotechnology
With its recent US Food and Drug Administration (FDA) approval, Eli Lilly’s Ebglyss (lebrikizumab) adds a new competitor to the atopic dermatitis (AD) market. 8 October 2024
Pharmaceutical
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Generics
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Pharmaceutical
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Biotechnology
US biotech major Amgen rolled out senior executives and a swish presentation in providing an update on two of its drugs in Phase III trials this week. 26 September 2024
Pharmaceutical
LEO Pharma has presented late-breaking data on the DELTA FORCE trial for Anzupgo (delgocitinib) cream as a potential treatment for adult patients with moderate to severe chronic hand eczema (CHE). 26 September 2024
Biotechnology
Belgian drugmaker UCB (Euronext: UCB) has announced the presentation of new four-year data in patients with moderate to severe plaque psoriasis treated with bimekizumab, the company’s IL-17A and IL-17F inhibitor that is marketed as Bimzelx. 25 September 2024
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